Open-Label Comparative Study of Risperidone Versus Olanzapine Versus Quetiapine for Mania in Children and Adolescents With Bipolar I and Bipolar II Disorder

This study has been completed.
Information provided by (Responsible Party):
Joseph Biederman, MD, Massachusetts General Hospital Identifier:
First received: September 14, 2005
Last updated: June 12, 2013
Last verified: June 2013
The objective of this study is to compare the safety and effectiveness of Risperidone, Olanzapine, and Quetiapine in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks and then over an extension phase. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

Condition Intervention Phase
Bipolar Spectrum Disorder
Drug: Risperidone
Drug: Olanzapine
Drug: Quetiapine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Young Mania Rating Scale [ Time Frame: baseline to 8 weeks ] [ Designated as safety issue: No ]
    Improvement defined as score reduction of 30% or greater.

Enrollment: 106
Study Start Date: June 2001
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Risperidone
    Open treatment with Risperidone
    Drug: Olanzapine
    Open treatment with Olanzapine
    Drug: Quetiapine
    Open treatment with Quetiapine

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Males and females age 6 to 18 years of age
  • Patient must have a diagnosis of bipolar I or bipolar II disorder and currently displaying an acute manic, hypomanic, or mixed episode (with or without psychotic features) according to the DSM-IV based on clinical assessment and confirmed by structured diagnostic interview (Kidd Schedule of Affective Disorders).
  • Patients must have an initial score on the Y-MRS total score of at least 15.
  • Patient must be able to participate in mandatory blood draws.
  • Patient must be able to swallow pills.

Exclusion Criteria:

  • Patients with chronic medical illness, DSM-IV substance dependence within the past 6 months, pregnant or nursing females, and those at serious risk of suicide will be excluded from the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT00182013

Sponsors and Collaborators
Massachusetts General Hospital
Principal Investigator: Joseph Biederman, MD MGH
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Joseph Biederman, MD, Principal Investigator, Massachusetts General Hospital Identifier: NCT00182013     History of Changes
Other Study ID Numbers: 2001P-000259 
Study First Received: September 14, 2005
Last Updated: June 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Quetiapine Fumarate
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Tranquilizing Agents processed this record on May 23, 2016